Devices and methods for positioning a spinal fixation element

ABSTRACT

Methods for delivering a spinal fixation element to a surgical site are provided herein. More specifically, the method includes delivering a plurality of percutaneous access devices to a corresponding number of spinal locations, inserting a spinal fixation element through tissue, and manipulating the element through opposed sidewall openings formed in each access device. In an exemplary embodiment, the method can be optimized for position of large-scale fixation elements (e.g., greater than about 95 mm in length). In addition, a manipulation instrument configured to position such spinal fixation elements is also provided herein.

FIELD OF USE

Methods and devices are provided herein for use in spinal surgery, andin particular to methods and devices for positioning a spinal fixationelement.

BACKGROUND

For a number of reasons, spinal fixation devices are used in orthopedicsurgery to align and/or fix a desired relationship between vertebralbodies. Such devices typically include a spinal fixation element, suchas a relatively rigid fixation rod, that is coupled to adjacentvertebrae by attaching the element to various anchoring devices, such ashooks, bolts, wires, or screws. The fixation elements can have apredetermined contour that has been designed according to the propertiesof the target implantation site, and once installed, the instrumentholds the vertebrae in a desired spatial relationship, either untildesired healing or spinal fusion has taken place, or for some longerperiod of time.

Spinal fixation elements can be anchored to specific portions of thevertebrae. Since each vertebra varies in shape and size, a variety ofanchoring devices have been developed to facilitate engagement of aparticular portion of the bone. Pedicle screw assemblies, for example,have a shape and size that is configured to engage pedicle bone. Suchscrews typically include a threaded shank that is adapted to be threadedinto a vertebra, and a head portion having a rod-receiving element,usually in the form of a U-shaped slot formed in the head. A set-screw,plug, or similar type of fastening mechanism is used to lock thefixation element, e.g., a spinal rod, into the rod-receiving head of thepedicle screw. In use, the shank portion of each screw is threaded intoa vertebra, and once properly positioned, a rod is seated through therod-receiving member of each screw and the rod is locked in place bytightening a cap or other fastener mechanism to securely interconnecteach screw and the fixation rod.

Recently, the trend in spinal surgery has been moving toward providingminimally invasive devices and methods for implanting spinal fixationdevices. One such method, for example, is disclosed in U.S. Pat. No.6,530,929 of Justis et al. and it utilizes two percutaneous accessdevices for implanting an anchoring device, such as a spinal screw, intoadjacent vertebrae. A spinal rod is then introduced through a thirdincision a distance apart from the percutaneous access sites, and therod is transversely moved into the rod-engaging portion of each spinalscrew. The percutaneous access devices can then be used to apply closuremechanisms to the rod-engaging heads to lock the rod therein. While thisprocedure offers advantages over prior art invasive techniques, thetransverse introduction of the rod can cause significant damage tosurrounding tissue and muscle. Moreover, the use of three separateaccess sites can undesirably lengthen the surgical procedure, andincrease patient trauma and recovery time.

In general, current minimally invasive procedures have been limited tothe use of relatively short spinal fixation elements (e.g., less thanabout 95 mm) thereby limiting the availability of minimally invasivesurgery in some spinal fusion procedures. For example, a 95 mm spinalfixation element is typically limited to a maximum of a three levelfusion. Thus, there remains a need for devices and methods capable ofproviding increased treatment options.

SUMMARY

Methods and instruments for delivering a spinal fixation element to asurgical site are provided herein. More specifically, the variousembodiments enable surgeons to perform high level spinal fusions(traversing three vertebra, four vertebra, five vertebra, etc.) by meansof minimally invasive surgical procedures. Thus, the methods andinstruments can be configured to allow for positioning of a large spinalfixation element (e.g., greater than about 95 mm in length) within aplurality of spinal anchors engaged to various spinal locations.Additionally, the disclosed surgical procedures can be configured tominimize the number of incisions thereby minimizing any tissue damage(and resulting patient discomfort) associated with the procedure.

Various aspects of the method are provided herein. For example, in oneaspect, the method includes engaging a plurality of percutaneous accessdevices to a corresponding number of spinal locations. Each accessdevice can be delivered to the respective spinal location via arespective incisions such that, for example, at least a first accessdevice is delivered via a first incision. Thus, the method can beconfigured to limit the number of required incisions to the number ofpercutaneous access devices being utilized in any given procedure. Eachpercutaneous access device can include a distal end disposed adjacent toa spinal anchor and a proximal end positioned outside a patient's body.The method next includes delivering a distal portion of a spinalfixation element through the first incision, manipulating the distalportion of the spinal fixation element through opposed sidewall openingsof the first percutaneous access device, and guiding the spinal fixationelement through opposed sidewall openings of each percutaneous accessdevice. As such, the spinal fixation element can be delivered throughthe percutaneous access devices from the outside of the first devicethereby eliminating the need to pass the fixation element longitudinallyalong an inner lumen of the access device. The method can furtherinclude placing the spinal fixation element within the plurality ofspinal anchors such that at least a portion of the spinal fixationelement resides within each of the plurality of spinal anchors, andreleasing the spinal fixation element from the manipulation instrumentfollowing the placing step.

As known to those of skill in the art, the spinal fixation element caninclude any such element capable of providing the desired spinal fusion.For example, in an exemplary embodiment, the spinal fixation element isa fixation rod. While the spinal fixation element can be of any desiredlength, in exemplary embodiments, the length of the spinal fixationelement is greater than about 95 mm, greater than about 100 mm, etc. Ingeneral, the length of the spinal fixation element is selected so as toachieve the desired level of spinal fusion (e.g., across threevertebrae, across four vertebra, across five vertebra, etc.).

As indicated, the method includes delivering a plurality of percutaneousaccess devices to a corresponding number of spinal locations. The numberof percutaneous access devices can vary depending on the procedure. Forexample, the method can utilize two such devices, three such devices,four such devices, or more than four such devices. Thus, the method canallow for a large number of such devices to be utilized thereby allowingfusions of greater levels and further allowing fusions spanning acrossvarious regions of the spine.

The percutaneous access devices can be configured in various manners.Generally, the devices include a distal end configured to releasablyengage a spinal anchor, and a proximal end positioned outside of apatient's body. In an exemplary embodiment, the proximal end of at leastone (or all) of the percutaneous access devices can be closed becausethe spinal fixation element is not being delivered axially along aninner lumen of the device but rather being delivered laterally throughopposed sidewall openings. As will be discussed, the use of apercutaneous access device having a closed proximal end facilitatesvarious downstream steps.

The spinal fixation element can be delivered and/or manipulated throughthe opposed sidewall openings of the various percutaneous access devicesin various manners. For example, in one aspect, the method can includereleasably engaging a proximal portion of the spinal fixation element toa distal portion of a manipulation instrument. As discussed below, themanipulation instrument can be configured in various manners so as tofacilitate the delivery and positioning of a relatively large-scalespinal fixation element at the surgical site. The method can furtherinclude disengaging the spinal fixation element from the manipulationinstrument after the spinal fixation element passes through the opposedsidewall openings of each percutaneous access device. In one suchembodiment, the releasably engaging step of the method can includedisposing the proximal end of the spinal fixation element within anopening formed in a distal portion of the manipulation instrument, andsecuring the spinal fixation element to the manipulation instrument byengaging a distal end of an engagement element to a notch formed in aproximal portion of the spinal fixation element wherein the engagementelement is disposed in a distal portion of the manipulation instrument.Also, the releasing step of the method can include applying an actuationforce to an actuator wherein the actuation force can disengage thedistal end of the engagement element from the notch formed in theproximal portion of the spinal fixation element.

In another aspect, a minimally invasive method for delivering a spinalfixation element to a surgical site is provided which includes insertinga plurality of access devices into a body through a percutaneousincision for each access device such that a proximal end of each accessdevice is positioned outside the body and a distal end engages a spinalanchor disposed in a vertebra. Next, the method can include inserting aspinal fixation element through one of the percutaneous incisions forone of the access devices such that a distal portion of the spinalfixation element is positioned adjacent an outer portion of a firstpercutaneous access device. Further, the method can include manipulatingthe spinal fixation element such that the spinal fixation element passesthrough the opposed sidewall openings of each percutaneous accessdevice. Once the spinal fixation element has been positioned through theopposed sidewall openings of each percutaneous access device, the methodcan further include placing the spinal fixation element in the pluralityof spinal anchors such that at least a portion of the spinal fixationelement resides within each bone anchor, and disengaging the spinalfixation element from the manipulation instrument following the placingstep.

In another aspect, a method for delivering a spinal fixation element toa surgical site is provided which includes engaging a plurality ofpercutaneous access devices to a corresponding number of spinallocations with each access device being delivered to the respectivespinal location via a respective incision such that at least a firstaccess device is delivered via a first incision wherein eachpercutaneous access device can include a distal end disposed adjacent toa spinal anchor and a proximal end positioned outside a patient's body.The method can also include releasably engaging a proximal portion of aspinal fixation element to a distal portion of a manipulation instrumentwherein the manipulation instrument includes a handle portion coupled toan elongate shaft via an offset. Further, the method can includedelivering a distal portion of the spinal fixation element through thefirst incision, and manipulating the distal portion of the spinalfixation element through opposed sidewall openings of the firstpercutaneous access device. The method can also include guiding thedistal portion of the spinal fixation element through opposed side wallopenings of each percutaneous access device, and placing the spinalfixation element within the plurality of spinal anchors such that atleast a portion of the spinal fixation element resides within the spinalanchors. Further, the method can also include releasing the spinalfixation element from the manipulation instrument following the aboveplacing step.

In addition to the various aspects of the method provided above, aninstrument for releasably engaging a spinal fixation element andpositioning the element percutaneously into a spinal anchor is providedherein. In one such aspect, the instrument can include a handle having aproximal end and a distal end. The instrument can also include an offsethaving a proximal end and a distal end wherein the proximal end of theoffset is coupled to the distal end of the handle and the distal end ofthe offset can extend into an elongate shaft. Further, the instrumentcan includes an opening formed in the distal end of the elongate shaftwherein the opening is configured to receive and releasably engage aproximal end of a spinal fixation element. Optionally, the distalportion of the elongate shaft can be configured to prevent passage ofthe shaft within a sidewall opening of a percutaneous access deviceattached to a spinal anchor.

The instrument can include various other components and/or featurescapable of facilitating placement and positioning of a spinal fixationelement. For example, in one embodiment, the instrument can include anactuator coupled to the shaft wherein the actuator is configured torelease an engaged spinal fixation element from the distal end of thedevice. Additionally, the instrument can include a distal portion of theelongate shaft which is angled relative to a proximal portion of theelongate shaft. As will be describe below, such an alignment canfacilitate proper positioning of the fixation element within the boneanchors.

In another aspect, the device for releasably engaging a spinal fixationelement and positioning the instrument can include a handle having aproximal end and a distal end wherein the distal end of the handle iscoupled to an elongate shaft by an offset. Further, a distal end of theelongate shaft can include an opening which is configured to receive aproximal end of a spinal fixation element. The distal end of theinstrument can also being configured to prevent passage of themanipulation instrument through a side-wall opening of a percutaneousaccess device. The instrument can also include an actuator coupled tothe distal shaft of the instrument wherein the actuator can be incommunication with an engagement element disposed within an inner lumenof the elongate shaft and being capable of moving the engagement elementinto and out of contact with a portion of the spinal fixation elementdisposed within the opening of the elongate shaft thereby retaining orreleasing the spinal fixation element from the device upon actuation.

These and other aspects of the presently disclosed methods and devicesare described in detail below.

BRIEF DESCRIPTION OF THE DRAWINGS

The various embodiments of the presently disclosed methods and deviceswill be more fully understood from the following detailed descriptiontaken in conjunction with the accompanying drawings, in which:

FIG. 1A is a representation of a plurality of percutaneous accessdevices engaged to a corresponding number of spinal locations;

FIG. 1B is a representation of a spinal fixation element being deliveredto a surgical site wherein the element is external and adjacent to afirst percutaneous access device of the plurality of such devices shownin FIG. 1A;

FIG. 1C is a representation of the spinal fixation element of FIG. 1Bbeing laterally passed through the opposed sidewall openings of severalof the percutaneous access devices of FIG. 1A;

FIG. 1D is a representation of the spinal fixation element of FIG. 1Bbeing positioned through the opposed sidewall openings of eachpercutaneous access devices and seated within spinal anchors associatedwith the percutaneous access devices;

FIG. 2A is a perspective view of an exemplary embodiment of apercutaneous access device releasably engaged to a spinal anchor;

FIG. 2B is a side view of the percutaneous access device of FIG. 2A;

FIG. 3A is a perspective view of an exemplary embodiment of amanipulation instrument;

FIG. 3B is a side view of the manipulation instrument of FIG. 3A;

FIG. 3C is a top view of another embodiment of a manipulationinstrument;

FIG. 4A is a view of a distal end of the manipulation instrument of FIG.3A;

FIG. 4B is a representation of an orientation between a proximal portionof a spinal fixation element and the distal end of the manipulationinstrument of FIG. 4A prior to engagement;

FIG. 5 is an exploded view of the manipulation instrument of FIG. 3A;and

FIG. 6 is a view of the distal end of the manipulation instrumentengaged to the spinal fixation element wherein the distal end of theinstrument is configured as a stop element.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the devices andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present disclosure is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the presently disclosed methods and devices.

Methods and devices for positioning a spinal fixation element at asurgical site are provided herein. In general, these methods and devicesfacilitate minimally invasive spinal fusion procedures that can spanmultiple levels of the spine (e.g., three levels or more) whileminimizing any associated tissue damage. For instance, the method caninclude delivering a plurality of percutaneous access devices to variousspinal locations via a corresponding number of incisions (e.g., fourpercutaneous access devices would require four incisions). Next, aspinal fixation element (e.g., a rigid rod, a polymer rod, a dynamicelement, etc.) can be delivered through tissue via one of the existingincisions such that, for example, the spinal fixation element can bepositioned adjacent an outer portion of a first percutaneous accessdevice and delivered through the first incision into the patient. Onceso positioned, the fixation element can be manipulated (e.g., via amanipulation instrument) so as to pass laterally through opposedsidewall openings of the first percutaneous access device andsubsequently through the remainder of the access devices via similarlypositioned opposed sidewall openings of each access device. Thus, thefixation element passes from the outside of the first percutaneousaccess device and transversely through the remainder of the devices. Aswill be discussed, such a delivery trajectory eliminates the need tointroduce the fixation element axially through a proximal opening of thefirst percutaneous access device as such delivery and subsequentmanipulation typically is difficult, if not impossible, when utilizing afixation element having a length of greater than about 95 mm.

An exemplary embodiment of a method for delivering a spinal fixationelement to the spine in a minimally invasive surgical technique isdepicted in FIGS. 1A-1D. As shown in FIG. 1A, the method includesengaging a plurality of spinal implant assemblies 10 a, 10 b, 10 c, 10d, 10 e to a plurality of spinal locations 20 a, 20 b, 20 c, 20 d, 20 e.While a variety of such assemblies can be used to perform the methodsdisclosed herein, FIGS. 2A and 2B illustrate an exemplary embodiment ofsuch an assembly 10 which includes a percutaneous access device 12 matedto a spinal anchor 50 that is embedded in a vertebral body. As shown,the percutaneous access device 12 can be in the form of a generallyelongate, cylindrical tube having a longitudinal axis L that extendsbetween proximal and distal ends 12 a, 12 b. The size of the accessdevice 12 can vary depending on the intended use. In certain exemplaryembodiments, for example, the percutaneous access device 12 may have alength 1 _(a) that allows the proximal end 12 a of the access device 12to be positioned outside the patient's body, while the distal end 12 bof the access device 12 is coupled to, or positioned adjacent to, aspinal anchor 50 that is disposed in a vertebra in a patient's spine.The exemplary percutaneous access device 12 may be implanted through aminimally invasive percutaneous incision, which is a relatively smallincision that typically has a length that is less than a diameter orwidth of the device 10 being inserted therethrough. For example, aminimally invasive percutaneous incision may be a stab or point incisionthrough which the percutaneous access device 12 is positioned. As willbe discussed, various embodiments of the method provided herein limitthe number of incisions to the number of percutaneous access devices 12required for the procedure.

The percutaneous access device 12 can further include opposed sidewallopenings 14 a, 14 b (opening 14 b is shown as dashed lines in FIG. 2A).As will be described, the opposed side wall openings 14 a, 14 b allowfor a spinal fixation element 30 to pass laterally through the accessdevice 12 thereby allowing for an optimized trajectory capable offacilitating the positioning of relatively longer fixation elements. Ingeneral, the width (W) of the sidewall openings 14 a, 14 b is generallysized in accordance with an outer diameter of the spinal fixationelement 30. Also, the sidewall openings 14 a, 14 b typically begin at alocation distal of the proximal end 12 a of the access device 12 andextend to the distal end 12 b of the device 12 thereby allowing the userto seat the fixation element 30 within the plurality of spinal anchors50 (discussed below). As will be apparent to those skilled in the art,the opposed sidewall openings 14 a, 14 b can have virtually any shape,width, length, etc. capable of allowing passage therethrough of thespinal fixation element 30.

Referring to FIG. 2A, the percutaneous access device 12 can also beconfigured to releasably engage a spinal anchor 50. Thus, the distal end12 b of the percutaneous access device 12 can include one or more matingelements 18 formed thereon or therein for engaging the anchor 50. In anexemplary embodiment, the mating elements 18 are formed on opposed innersurfaces of the distal end 12 b of the access device 12. As will beapparent to those skilled in the art, a wide range of such matingelement can be utilized with the presently disclosed devices andmethods. For example, the mating elements can include threads, atwist-lock engagement, a snap-on engagement, a dovetail coupling, or anyother technique known in the art. In an exemplary embodiment, apercutaneous access device can be coupled to a corresponding bone anchorvia a break-off coupling as disclosed in assignee's co-pending U.S.patent application Ser. No. 11/561,455, entitled “Break-off ScrewExtensions,” filed on Nov. 20, 2006, the entirety of which isincorporated herein by reference. Exemplary techniques for mating thepercutaneous access device 12 to an anchor 50 are disclosed in commonlyowned U.S. Pat. No. 7,179,261, entitled “Percutaneous Access Devices andBone Anchor Assemblies,” which is incorporated by reference in itsentirety herewith. Those skilled in the art will appreciate that avariety of other techniques can be used to removably mate thepercutaneous access device 12 to an anchor 50.

A variety of spinal anchors 50 can be used with the presently disclosedpercutaneous access device(s) 12, including, for example, spinal screws,hooks, bolts, and wires. FIG. 2A illustrates a spinal screw thatincludes a distal, bone-engaging portion, e.g., a threaded shank 54, anda proximal, U-shaped receiver member head 52 that is adapted to seat aspinal fixation element 30, for example a fixation rod. The threadedshank 54 can be fixedly attached to the receiver head 52 to form amonoaxial screw, or alternatively the shank 54 can be configured as apolyaxial screw, as shown, that is rotatably disposed through an openingformed in the distal end of the receiver head 52 to allow rotation ofthe shank 54 with respect to the receiver head 52. A variety oftechniques can be used to allow rotation of the head 52 with respect tothe shank 54.

As indicated above, the method can include delivering any number ofspinal implant assemblies 10 a, 10 b, 10 c, etc. to a correspondingnumber of spinal locations 20 a, 20 b, 20 c, etc. (e.g., vertebrae) asrequired by a given procedure. For example, the method can includedelivering two assemblies 10 a, 10 b, three assemblies 10 a, 10 b, 10 c,four assemblies 10 a, 10 b, 10 c, 10 d, etc. In the exemplary embodimentof FIG. 1A, the method includes engaging five assemblies 10 a, 10 b, 10c, 10 d, 10 e (i.e., spinal anchor 50 and associated percutaneous accessdevice 12) to five respective spinal locations 20 a, 20 b, 20 c, 20 d,20 e thereby allowing for a four-level spinal fusion.

Following placement of the various assemblies 10 a, 10 b, 10 c, etc., aspinal fixation element 30 can be delivered to the surgical site alongan optimized trajectory and manipulated so as to seat the element 30within the plurality of spinal anchors 50. The spinal fixation element50 can be delivered through the same incision that accommodates one ofthe access devices 12, such as the most cephalad or caudal accessdevice. FIGS. 1B-1D illustrate delivery of the spinal fixation element30 from its point of insertion along a trajectory which facilitatespositioning of a large-scale (e.g., greater than about 95 mm in length)spinal fixation element 30. More specifically, FIG. 1B shows theplurality of percutaneous access devices 12 engaged to a plurality ofspinal locations 20 a, 20 b, etc. wherein each access device 12 isdelivered via an individual incision and associated pathway. Once thesedevices 12 are so positioned, a distal portion 30 a of the spinalfixation element 30 can be positioned adjacent an outer portion of afirst percutaneous access device 12 and subsequently inserted throughthe corresponding first incision and delivered to a position adjacent tothe distal end 12 b of the percutaneous access device 12 as shown inFIG. 1B. Thus, the spinal fixation element 30 is delivered through thetissue via the same incision created for the delivery of the firstpercutaneous access device 12 thereby eliminating the need to createadditional incision(s) to accommodate the fixation element. The spinalfixation element 30 can be delivered at any angle capable offacilitating delivery and placement of the element 30 relative to theplurality of access device(s) 12. For example, the spinal fixationelement 30 can be delivered substantially parallel to a longitudinalaxis (L) of the percutaneous access device 12. In other embodiments, thespinal fixation element 30 can be delivered at an angle of about 45° orless relative to the longitudinal axis (L) of the percutaneous accessdevice 12.

Referring to FIG. 1C, the fixation element 30 can be further bemanipulated so as to insert the distal end 30 a of the element 30laterally through the opposed sidewall openings 14 a, 14 b of the firstpercutaneous access device 30. Once the fixation element 30 has passedthrough the sidewall openings 14 a, 14 b of the first percutaneousaccess device 12, the element 30 is further advanced through the opposedsidewall openings of all additional percutaneous access devices 12 ofthe remaining assemblies 10 b, 10 c, 10 d, 10 e. Finally, as shown inFIG. 1D, the spinal fixation element 30 is positioned through theopposed sidewall openings 14 a, 14 b of each percutaneous access device12 and placed within the plurality of spinal anchors 50 disposed withinthe various spinal locations 20 a, 20 b, 20 c, 20 d, 20 e such that atleast a portion of the spinal fixation element resides within each ofthe plurality of spinal anchors 50. Following this placing step, thespinal fixation element 30 can then be detached from a manipulationinstrument 40 (discussed below) and the instrument 40 can be withdrawnfrom the treatment site. The ability to securely engage the fixationelement 30 during placement and positioning of the element 30 within theplurality of bone anchors 50 in contrast to releasing the fixationelement 30 and attempting to manually (or by means of additionaldevices) position the element 30 can significantly improve theefficiency and effectiveness of the stabilization procedure. The methodcan further include a mechanism for securing the spinal fixation element30 to the plurality of spinal anchors 50, for example, by threading aplurality of set screws (not shown) into the plurality of spinal anchors50.

In light of the above-described delivery trajectory, the percutaneousaccess devices 12 can include closed proximal ends 12 a therebyproviding various advantages. For example, closed end devices are easierto manipulate and/or engage additional instrumentation thereto ascompared to open-ended devices. Further, the use of such closed proximalend devices 12 a allows for a single percutaneous access device 12 to beemployed as compared to common procedures requiring both closed and openended devices wherein the use of a single type of access device 12facilitates the user's ability to determine the depth of the accessdevice 12 relative to the tissue and also facilitates the user's abilityto determine if any of the devices are misaligned. For at least thesereasons, the use of percutaneous access devices 12 having closedproximal ends 12 a provides significant advantages over commonly knowntechniques and devices.

As indicated above, the spinal fixation element 30 can include virtuallyany element capable of providing the desired spinal fixation. Forexample, the spinal fixation element 30 can be a rigid rod (e.g., atitanium rod), a polymer rod, and/or a dynamic element. In someembodiments, the fixation element can include a variable diameter alonga length of the element. Additionally, the length and/or dimensions ofthe fixation element can be selected and/or configured as required by agiven procedure. For example, in an exemplary embodiment, the spinalfixation element 30 can have a length greater than about 95 mm. In otherembodiments, the spinal fixation element 30 can have a length greaterthan about 100 mm, greater than about 105 mm, greater than about 110 mm,greater than about 120 mm, etc. It will be apparent to those skilled inthe art that a spinal fixation element 30 can have any length asrequired by a given procedure. For example, the fixation element canhave a length suitable for a 2-level procedure (i.e., a singleconstruct), 3-level procedure, a 4-level procedure, a 5-level procedure,or greater level procedure. Additionally, the spinal fixation elementcan be straight, pre-contoured to match the desired curvature of thespine in the appropriate region, or bendable by a surgeon to achieve adesired contour.

In addition to the methods provided above, various embodiments of amanipulation instrument 40 configured to facilitate positioning and/ormanipulation of the element 30 are also provided herein. As describedbelow, the manipulation instrument 40 can be configured in variousmanners to facilitate delivery of a large-scale fixation element 30 aswell as proper positioning of the element within the various spinalanchors. Such a manipulation instrument, as well as other componentsdescribed herein, can be provided as part of a kit or system. FIGS.3A-3C provide various views of an exemplary embodiment of a manipulationinstrument 40 capable of releasably engaging and delivering a spinalfixation element 30 to a desired surgical site. As shown, the instrument40 can include a shaft 44 having a proximal end coupled to a handle 42and a distal end coupled to a clamping mechanism 46. In order tofacilitate manipulation of large-scale fixation elements 30, the shaft44 of the instrument 40 can be offset relative to the handle 42 suchthat the handle 42 is not collinear with the clamping mechanism 46thereby positioning the handle 42 away from the patient which enhancesmaneuverability and/or visibility as the user manipulates the spinalfixation element 30 into a desired position (see FIG. 1C). Such anoffset configuration can be achieved in various ways. For example, asshown in FIG. 3A the shaft 44 can include a first length L₁, a secondlength L₂ and a third length L₃ wherein the second length L₂ is orientedat an angle θ_(a) relative to the first length L₁. Also, as will befurther described below, the above-described configuration of theinstrument 40 (e.g., the offset and various curves) can allow for easieraccess to an actuator 64 b configured to release a spinal fixationelement engaged to the instrument 40. Additionally, the distal portionof the clamping mechanism 46 can be configured to be at an angle θ_(b)relative to the proximal end of the clamping mechanism 46 therebyensuring proper positioning of the fixation element 30 within the spinalanchors. More specifically, angling the clamping mechanism 46 as suchensures that the fixation element is completely positioned within thefirst bone anchor as opposed to over-insertion of the element 30 whichcould prevent a closure mechanism from properly securing the fixationelement 30 within the first bone anchor.

The handle 42 of the instrument 40 can also be configured to provideenhanced maneuverability and/or control over the fixation element duringdelivery to the surgical site. For example, the handle 42 can beoversized (e.g., large diameter and/or length) so as to provide leverageto a user relative to the fixation element. Such added leverage andenhanced control can be of increased importance for those proceduresrequiring the use of large fixation elements. Additionally, asillustrated in FIG. 3C, the handle 42 can be angled relative to theshaft thereby facilitating delivery of the fixation element. As will beappreciated by those skilled in the art, the handle can be configured invarious other manners so as to improve the user's ability to accuratelydeliver and/or position the fixation element.

As indicated above, the instrument 40 can include a clamping mechanism46 having a distal portion 48 configured to releasably engage the spinalfixation element 30. For example, as shown in FIGS. 4A and 4B, thedistal portion 48 of the clamping mechanism 46 can include an opening 48o configured to receive the proximal end 30 a of the spinal fixationelement 30. When the proximal end 30 a of the fixation element 30 ispositioned within the opening 48 o, the element 30 can be securedtherein by various mechanisms. For example, as will be explained ingreater detail in relation to FIG. 5, the clamping mechanism 46 can bein communication with an actuator 64 b configured to allow a user toselectively engage or disengage the fixation element 30. FIG. 5 providesan exploded view of the manipulation instrument 40 to illustrate theinner workings of the clamping mechanism 46. As shown, the instrument 40is comprised of various components such as the clamping mechanism 46,the shaft 44, and the handle 42. In such an embodiment, the variouscomponents can be coupled to one another via any well known method(e.g., use of a ball plunger 66). In other embodiments, any or all ofthese components 42, 44, 46 can be permanently mated to one another orcan be formed as a single component. Referring to the clamping mechanism46, a distal portion 47 (see FIG. 3B) of the mechanism 46 can be angled(θ_(b)) so as to ensure proper positioning of the fixation element 30within the bone anchors. Additionally, the clamping mechanism 46 caninclude a central bore (not shown) extending therethrough and incommunication with the distal opening 48 o thereby allowing anengagement element 60 and a driver 64 to slide along the central bore soas to engage and/or disengage the fixation element 30. As will bedescribed, these elements 60, 64 can be configured to slide along thecentral bore in response to a force supplied to the actuator 64 b. Inthis example, the elements 60, 64 will be shown as distinct elements.However, as will be clear to those skilled in the art, these componentscould be a single element or more than two elements.

Thus, in the exemplary embodiment shown in FIG. 5, the engagementelement 60 can include a distal end 60 a configured to securely engagethe proximal portion 30 b of the fixation element 30. As illustrated inFIG. 4B, in a biased state, the distal portion 60 a of the engagementelement 60 resides in a retracted position within the clamping mechanism46. Upon actuation (described below), the distal portion 60 a isadvanced distally so as to engage a corresponding groove 31 (FIG. 4B) ofthe fixation element 30. The engagement element 60 further includes aproximal end 60 b configured to have a larger diameter as compared tothe remainder of the element 60 thereby allowing a resilient element(e.g., a spring) 62 to be positioned over the element 60 and sized toabut the enlarged distal portion 60 b. When assembled, a distal portionof the spring 62 can engage the surrounding walls of the inner borethereby resulting in the above-described biased, retracted position. Aswill be shown below, in use, the user can supply a force to the actuator64 b which results in the spring 62 being compressed and the distal end60 a of the engagement element 60 being brought into contact with theportion of fixation element 30 disposed within the distal opening 48 o.Additionally, a slot 68 can be incorporated within the engagementcomponent 60 such that the slot 68 is configured to receive a set-pin 70disposed through a hole 72 in the distal portion of the clampingmechanism 46. Thus, the set-pin 70 and the associated slot 68 can beconfigured to limit movement of the engagement element 60 between thebiased, retracted position and the extended position.

As mentioned, in this exemplary embodiment, a driver 64 can be incommunication with the engagement element 60 such that the driver 64 cantranslate a force from the actuator 64 b to the engagement element 60.Thus, as shown, the driver 64 can include a distal end 64 a configuredto abut the proximal end 60 b of the engagement element 60, and thedriver 64 can further include the actuator 64 b at the proximal end andaccessible to a user. A proximal portion of the driver 64 (distal of theactuator 64 b) can include a threaded portion 63 configured to engage acorresponding threaded portion (not shown) incorporated into theclamping mechanism 46. Thus, by rotating the actuator 64 b in a firstdirection (e.g., clockwise), the driver 64 can advance in a distaldirection via the threaded portions. As the driver 64 advances, a forceis supplied to the engagement element 60 thereby overcoming the biasingforce of the spring 62 and forcing the distal end 60 a of the engagementelement 60 against the proximal end 30 b of the spinal fixation element30. Upon rotating the actuator 64 b in an opposite direction (e.g.,counter clockwise), the force is removed and the engagement element 60is free to return to the biased, retracted position. Referring onceagain to FIG. 5, the clamping mechanism 46 can also include a removableportion 74 thereby allowing for maintenance, cleaning, and/orrepair/replacement of any of the various internal components. In otherembodiments, the portion 74 is welded in position.

In another embodiment, the manipulator instrument 40 can be configuredto facilitate proper positioning of the spinal fixation element 30relative to the plurality of percutaneous access devices 12 andcorresponding spinal anchors 50. For example, as illustrated in FIG. 6,a distal end 48 of the clamping mechanism 46 can be configured toprevent passage of the distal portion 48 within and/or through thesidewall opening of the first percutaneous access device 12 therebyindicating to the user when the spinal fixation element 30 has beendelivered through each of the assemblies 10 a, 10 b, etc. utilized bythe given procedure. The distal end 48 of the extension can includevarious configurations capable of achieving the desired result. In anexemplary embodiment, the distal portion 48 of the clamping mechanism 46can be substantially planar and has a diameter larger than of the spinalfixation element 30. Those skilled in the art will appreciate that thedistal end 48 can include virtually any such configuration capable ofpreventing passage of the distal end 48 of the clamping mechanism 46within and/or through the opposed sidewall openings.

One skilled in the art will appreciate further features and advantagesof the presently disclosed methods and/or devices based on theabove-described embodiments. Accordingly, the disclosure is not to belimited by what has been particularly shown and described, except asindicated by the appended claims. All publications and references citedherein are expressly incorporated herein by reference in their entirety.

1. A method for delivering a spinal fixation element to a surgical site,comprising: engaging a plurality of percutaneous access devices to acorresponding number of spinal locations, each access device beingdelivered to the respective spinal location via a respective incisionsuch that at least a first access device is delivered via a firstincision, each percutaneous access device having a distal end disposedadjacent to a spinal anchor and a proximal end positioned outside apatient's body; releasably engaging a proximal end of a spinal fixationelement to a manipulation instrument; delivering a distal portion of thespinal fixation element through the first incision; manipulating thedistal portion of the spinal fixation element through opposed sidewallopenings of the first percutaneous access device; guiding the distalportion of the spinal fixation element through opposed side wallopenings of each percutaneous access device; placing the spinal fixationelement within the plurality of spinal anchors such that at least aportion of the spinal fixation element resides within each of theplurality of spinal anchors; and releasing the spinal fixation elementfrom the manipulation instrument following the placing step.
 2. Themethod of claim 1, wherein the spinal fixation element is a rod.
 3. Themethod of claim 1, wherein the spinal fixation element has a lengthconfigured to provide a three-level spinal fixation.
 4. The method ofclaim 1, wherein the spinal fixation element has a length configured toprovide at least a four-level spinal fixation.
 5. The method of claim 1,wherein three percutaneous access devices are utilized.
 6. The method ofclaim 1, wherein at least four percutaneous access devices are utilized.7. The method of claim 1, wherein the proximal end of at least onepercutaneous access device is closed.
 8. The method of claim 1, whereinthe proximal end of at least one percutaneous access device is open. 9.The method of claim 1, wherein the releasably engaging step comprises:disposing the proximal end of the spinal fixation element within anopening formed in a distal portion of the manipulation instrument; andsecuring the spinal fixation element to the manipulation instrument byengaging a distal end of an engagement element to a notch formed in aproximal portion of the spinal fixation element, the engagement elementbeing disposed within a distal portion of the manipulation instrument.10. The method of claim 9, wherein the releasing step comprises:applying an actuation force to an actuator coupled to the manipulationinstrument wherein the actuation force disengages the distal end of theengagement element from the notch formed in the proximal portion ofspinal fixation element.
 11. A minimally invasive method for deliveringa spinal fixation element to a surgical site, comprising: inserting aplurality of access devices into a body through a percutaneous incisionfor each access device such that a proximal end of each access device ispositioned outside the body and a distal end engages a spinal anchordisposed in a vertebra; engaging a proximal portion of a spinal fixationelement to a distal portion of a manipulation instrument; inserting thespinal fixation element through one of the percutaneous incisions forone of the access devices such that a distal portion of the spinalfixation element is positioned adjacent an outer portion of a firstpercutaneous access device; manipulating the spinal fixation elementsuch that the spinal fixation element passes through the opposedsidewall openings of each percutaneous access device; placing the spinalfixation element in the plurality of spinal anchors such that at least aportion of the spinal fixation element resides within each bone anchor;and disengaging the spinal fixation element from the manipulationinstrument following the placing step.
 12. The method of claim 11,wherein the spinal fixation element is a rod.
 13. The method of claim11, wherein the spinal fixation element has a length configured toprovide a three-level spinal fixation.
 14. The method of claim 11,wherein the spinal fixation element has a length configured to provideat least a four-level spinal fixation.
 15. The method of claim 11,wherein the releasably engaging step comprises: disposing the proximalend of the spinal fixation element within an opening formed in a distalportion of the manipulation instrument; and securing the spinal fixationelement to the manipulation instrument by engaging a distal end of anengagement element to a notch formed in a proximal portion of the spinalfixation element, the engagement element being disposed within a distalportion of the manipulation instrument.
 16. The method of claim 15,wherein the releasing step comprises: applying an actuation force to anactuator coupled to the manipulation instrument wherein the actuationforce disengages the distal end of the engagement element from the notchformed in the proximal portion of spinal fixation element.
 17. A methodfor delivering a spinal fixation element to a surgical site, comprising:engaging a plurality of percutaneous access devices to a correspondingnumber of spinal locations, each access device being delivered to therespective spinal location via a respective incision such that at leasta first access device is delivered via a first incision, eachpercutaneous access device having a distal end disposed adjacent to aspinal anchor and a proximal end positioned outside a patient's body;releasably engaging a proximal portion of a spinal fixation element to adistal portion of a manipulation instrument, the manipulation instrumenthaving a handle portion coupled to an elongate shaft via an offset;delivering a distal portion of the spinal fixation element through thefirst incision; manipulating the distal portion of the spinal fixationelement through opposed sidewall openings of the first percutaneousaccess device; guiding the distal portion of the spinal fixation elementthrough opposed side wall openings of each percutaneous access device;placing the spinal fixation element within the plurality of spinalanchors such that at least a portion of the spinal fixation elementresides within the spinal anchors; and releasing the spinal fixationelement from the manipulation instrument following the above placingstep.
 18. The method of claim 17, wherein a distal portion of theelongate shaft is angled relative to a proximal portion of the elongateshaft.
 19. The method of claim 17, further comprising: contacting adistal end of the manipulation instrument to a distal portion of a firstpercutaneous access device, the distal end of the manipulationinstrument configured to prevent passage of the instrument through theopposed side-wall openings, the contacting step performed prior to thereleasing step.
 20. A device for releasably engaging a spinal fixationelement and positioning the element percutaneously into a spinal anchor,comprising: a handle having a proximal end and a distal end; an offsethaving a proximal end and a distal end, the proximal end of the offsetcoupled to the distal end of the handle and the distal end of the offsetextending into an elongate shaft; and an opening formed in the distalend of the elongate shaft, the opening being configured to receive andreleasably engage a proximal end of a spinal fixation element.
 21. Thedevice of claim 20, wherein the distal portion of the elongate shaft isconfigured to prevent passage of the shaft within a sidewall opening ofa percutaneous access device attached to a spinal anchor.
 22. The deviceof claim 20, further comprising: an actuator coupled to the shaft, theactuator configured to release an engaged spinal fixation element fromthe distal end of the device.
 23. The device of claim 20, wherein adistal portion of the elongate shaft is angled relative to a proximalportion of the elongate shaft.
 24. A device for releasably engaging aspinal fixation element and positioning the element percutaneously intoa plurality of spinal anchors, comprising: a handle having a proximalend and a distal end, the distal end of the handle being coupled to anelongate shaft by an offset; a distal end of the elongate shaft havingan opening configured to receive a proximal end of a spinal fixationelement, the distal end also being configured to prevent passage of themanipulation instrument through a side-wall opening of a percutaneousaccess device; and an actuator coupled to the distal shaft of theinstrument, the actuator being in communication with an engagementdisposed within an inner lumen of the elongate shaft and being capableof moving the engagement element into and out of contact with a portionof the spinal fixation element disposed within the opening of theelongate shaft thereby retaining or releasing the spinal fixationelement from the device upon actuation.
 25. The device of claim 24,wherein a distal portion of the elongate shaft is angled relative to aproximal portion of the elongate shaft.